The many parts of the health care bill are a marvel to contemplate and as the 2000 plus pages are deciphered there will be much to be considered.
Here is one that has received a bit more commentary than my current favorite worry,section 10320. See here for my fears about 10320.
Jason Shafin, Phd in economics, discussed the CLASS act in the above hyperlink. Class stands for Community Living Assistance Services and Support Act . This is a Long Term Care (LTC) program whose benefits seem grossly inadequate to pay for a nursing home but admittedly might help a bit.Funding for it precedes the years when payouts occur, part of the wink-wink-nudge-nudge accounting that achieved the veneer and illusion of "cost saving" of this landmark bill.
This is a voluntary program that may be offered by employers and applicants cannot be denied coverage. There are some interesting tricks in the program that Dr. Shafin warns us about. The default position regarding employees is that they are signed up unless they opt out.I suppose this the so-called libertarian paternalism at work. But, if you drop out after you figure out you are in it, you then have a penalty to pay if you decide you really want it after you get older and realize you might need it and sign up for the plan again. Not sure how paternalistic that is, maybe some type of tough love.
Tuesday, April 06, 2010
Monday, April 05, 2010
Section 10320 of health care bill-reason to be afraid
Section 10320 of the health care bill changes the focus and greatly enhance the influence of the IMAB.Again h/t to DrRick. The phrase "greatly enhanced" does not begin to capture the enormity of what that change could be.
The IMAB ( Independent Medicare Advisory Board) has been characterized as a rather benign entity merely existed to make suggestions regarding how to improve Medicare and benefit everyone over 65. But things seem to get really interesting in 2014. The initials changes to IPAB or the Independent Payment Advisory Board.
The title of section 10320 is illuminating ;“Expansion Of The Scope Of, And Additional Improvements To, The Independent Medicare Advisory Board.”
"Improvements" are in the eye of the beholder but in what way is the scope expanded? The board is directed to periodically (every 2 years) to submit recommendations to slow the growth in national health expenditures for private (non-Federal) health care programs.,such recommendations to be implemented administratively by the HHS Secretary and/or other such Federal agency heads.
Is it even possible for a federal agency to control private health care expenditures? Does this mean that the HHS secretary, a political appointee, could deny what would otherwise be a lawful contractual relationship between a person and an insurance company? For example HHS could write regulations forbidding an insurance company from paying for a brain MRI in a patient over 65. Having control of insurance coverage is a powerful tool that has now been taken over by the federal government.
Would the power of HHS extend to control private ( non insurance related) activities between a patient and a physician? It is easy to imagine how that could happen. Simply issue a regulation (aka edict) that disallows a physician who receives CMS funds from taking part in any private financial arrangements with a patient.
Does the creation of the IPAB make it possible for a government appointed administrator basically determine if health care in this country will go the way of Great Britain or Canada, with "allowed"private care in the former and not in the latter.
Here is more detail on 10320 and how it activities morph further as times goes by, e.g taking GNP into its calculus to control national (public and private) health care costs.
This topic deserves far more discussion and recognition by the public and by the medical profession. It deserved much more discussion before it was passed.When you Google "section 10320" and my earlier blog entry shows up on the first page of hits (as of 4.4.2010), you know that this needs more widespread discussion.
Here is a letter sent from dozens of health related organizations opposing the creation of the IPAB.
Interestedly, absent from the list are the AMA and ACP.
The IMAB ( Independent Medicare Advisory Board) has been characterized as a rather benign entity merely existed to make suggestions regarding how to improve Medicare and benefit everyone over 65. But things seem to get really interesting in 2014. The initials changes to IPAB or the Independent Payment Advisory Board.
The title of section 10320 is illuminating ;“Expansion Of The Scope Of, And Additional Improvements To, The Independent Medicare Advisory Board.”
"Improvements" are in the eye of the beholder but in what way is the scope expanded? The board is directed to periodically (every 2 years) to submit recommendations to slow the growth in national health expenditures for private (non-Federal) health care programs.,such recommendations to be implemented administratively by the HHS Secretary and/or other such Federal agency heads.
Is it even possible for a federal agency to control private health care expenditures? Does this mean that the HHS secretary, a political appointee, could deny what would otherwise be a lawful contractual relationship between a person and an insurance company? For example HHS could write regulations forbidding an insurance company from paying for a brain MRI in a patient over 65. Having control of insurance coverage is a powerful tool that has now been taken over by the federal government.
Would the power of HHS extend to control private ( non insurance related) activities between a patient and a physician? It is easy to imagine how that could happen. Simply issue a regulation (aka edict) that disallows a physician who receives CMS funds from taking part in any private financial arrangements with a patient.
Does the creation of the IPAB make it possible for a government appointed administrator basically determine if health care in this country will go the way of Great Britain or Canada, with "allowed"private care in the former and not in the latter.
Here is more detail on 10320 and how it activities morph further as times goes by, e.g taking GNP into its calculus to control national (public and private) health care costs.
This topic deserves far more discussion and recognition by the public and by the medical profession. It deserved much more discussion before it was passed.When you Google "section 10320" and my earlier blog entry shows up on the first page of hits (as of 4.4.2010), you know that this needs more widespread discussion.
Here is a letter sent from dozens of health related organizations opposing the creation of the IPAB.
Interestedly, absent from the list are the AMA and ACP.
Friday, April 02, 2010
Could the Independent Medicare Advisory Board pave the way to an exclusive single payer?
I have written before that perhaps the worst part of the Obama health care redo is the incredible delegation of wide- almost unlimited- powers to a political appointee ( the secretary of HHS).
Scrutiny of the behemoth legislation by Dr. Fogoros (AKA DrRick of the Covert Rationing Blog) Rationing) has brought to light that fact that in 2015 the Independent Medicare Advisory Board morphs into an entity named the Independent Payment Advisory Board. See here for details as provided by Dr.Rick.
This is much more than a change in initials from IMAB to IPAB. It give the HHAS secretary authority to somehow issue administrative rules that will somehow limit private medical expenditure.
From DrRick:
Section 10320 changes the name of the Immutables from the Independent Medicare Advisory Board to the Independent Payment Advisory Board. It directs the Immutables (and now readers will understand why DrRich has resorted to this more descriptive name), at least every two years, to “submit to Congress and the President recommendations to slow the growth in national health expenditures” for private (non-Federal) healthcare programs. Furthermore, it allows that these “recommendations” may be implemented by the Secretary of HHS or other Federal agencies administratively.
Does this administrative power pave the way to limit what an individual might pay on his own for health care?
It need not but it could. The HHS czar could decree according to Section 10320 that no insurance plan could include coverage for something or other ( perhaps screening colonoscopy for folks over 65) and leave it at that. OR HHS could decree that no practitioner would receives Medicare/Medicare funds or payments for an insurance policy obtained from an exchange could enter into any financial relationship with a patient outside of that which is expressly provided by the plan. In other words more like Great Britain or more like Canada. I wonder how many House members who were herded into voting for the bill realized that much of the future of health care for millions of folks would be determined by a political appointee?
If you agree with many folks that the passage of the health care bill was an abuse of power (see Here),wait until we see what 2015 and the Department of HHS have to offer.
Scrutiny of the behemoth legislation by Dr. Fogoros (AKA DrRick of the Covert Rationing Blog) Rationing) has brought to light that fact that in 2015 the Independent Medicare Advisory Board morphs into an entity named the Independent Payment Advisory Board. See here for details as provided by Dr.Rick.
This is much more than a change in initials from IMAB to IPAB. It give the HHAS secretary authority to somehow issue administrative rules that will somehow limit private medical expenditure.
From DrRick:
Section 10320 changes the name of the Immutables from the Independent Medicare Advisory Board to the Independent Payment Advisory Board. It directs the Immutables (and now readers will understand why DrRich has resorted to this more descriptive name), at least every two years, to “submit to Congress and the President recommendations to slow the growth in national health expenditures” for private (non-Federal) healthcare programs. Furthermore, it allows that these “recommendations” may be implemented by the Secretary of HHS or other Federal agencies administratively.
Does this administrative power pave the way to limit what an individual might pay on his own for health care?
It need not but it could. The HHS czar could decree according to Section 10320 that no insurance plan could include coverage for something or other ( perhaps screening colonoscopy for folks over 65) and leave it at that. OR HHS could decree that no practitioner would receives Medicare/Medicare funds or payments for an insurance policy obtained from an exchange could enter into any financial relationship with a patient outside of that which is expressly provided by the plan. In other words more like Great Britain or more like Canada. I wonder how many House members who were herded into voting for the bill realized that much of the future of health care for millions of folks would be determined by a political appointee?
If you agree with many folks that the passage of the health care bill was an abuse of power (see Here),wait until we see what 2015 and the Department of HHS have to offer.
Thursday, April 01, 2010
Health care "reform:,wouldn't it be nice to think so?
A recent commentary by Sheldon Richman has so many insights into what the health care bill offers,will offer and as to what it means that it must be read in its entirety. See here. All I can add is "amen".
Here are some of the major issues he raises.
Richman tell us that what "everyone" is provided with is not insurance at all
OPR [ stands for the Obama-Pelosi-Reid bill ] will directly subvert what is left of the insurance market and indirectly subvert what is left of the medical market. Insurance is about pooling risk in the face of an uncertain future. But OPR requires that insurance companies cover people without taking risk or even certainty (preexisting conditions) into consideration. There are no grounds for calling this insurance. Rather, it is welfare mixed with prepayment for future services. (Not that the insurers are complaining; it’s a price they’ll gladly pay for the captive customers that the mandate will deliver.)
Remember "fast,good and cheap" , pick any two. There is something similar with OPR, but I think you can pick only any one.
Adding insult to injury, OPR falsely promises that we can have government-subsidized consumption of medical services, lower prices, and freedom of choice at the same time. In fact, those three things cannot coexist. Subsidies will boost consumption, which will raise prices. If government is serious about lowering prices, it will have to curtail consumption, that is, limit freedom of choice, explicitly through rationing or implicitly through price controls and standards of practice.
And perhaps most important is that fact that no one really knows what is in the bill because much that will come out of the legislation is undefined and is to be determined by the Secretary of HHS and other panel and bureau heads.
Finally, OPR puts another nail in the coffin of government transparency. Regardless of how much or little government (if any) people want, they should at least be able to see and understand what it is up to and how much it costs them personally. In every way OPR flouts this principle. The law’s 2,700 pages of impenetrable “English” was read in its entirety by few if anyone. But that only begins to describe the offense. The law leaves much to be defined in the future by government departments, boards, and commissions. Hundreds of rules and regulations have yet to be written – and who do you think will be right there offering counsel as the new insurance rules are formulated? The same insurance companies whom last week were said to be the devil incarnate. (And Organized Medicine and Big Pharma too.) That’s how the Washington game is played. And we’re the losers.
I agree,organized medicine (at least the AMA and ACP) were on hand to "offer council" but while Pharma may have made out OK ( I say" may" because all of the fall out has not begun to fall ) organized medicine,IMHO, didn't get much to show for their lobbying efforts.The small dollops to physicians are more illusory than real and a very small price to approve giving massive power to the Secretary of HHS.
Here are some of the major issues he raises.
Richman tell us that what "everyone" is provided with is not insurance at all
OPR [ stands for the Obama-Pelosi-Reid bill ] will directly subvert what is left of the insurance market and indirectly subvert what is left of the medical market. Insurance is about pooling risk in the face of an uncertain future. But OPR requires that insurance companies cover people without taking risk or even certainty (preexisting conditions) into consideration. There are no grounds for calling this insurance. Rather, it is welfare mixed with prepayment for future services. (Not that the insurers are complaining; it’s a price they’ll gladly pay for the captive customers that the mandate will deliver.)
Remember "fast,good and cheap" , pick any two. There is something similar with OPR, but I think you can pick only any one.
Adding insult to injury, OPR falsely promises that we can have government-subsidized consumption of medical services, lower prices, and freedom of choice at the same time. In fact, those three things cannot coexist. Subsidies will boost consumption, which will raise prices. If government is serious about lowering prices, it will have to curtail consumption, that is, limit freedom of choice, explicitly through rationing or implicitly through price controls and standards of practice.
And perhaps most important is that fact that no one really knows what is in the bill because much that will come out of the legislation is undefined and is to be determined by the Secretary of HHS and other panel and bureau heads.
Finally, OPR puts another nail in the coffin of government transparency. Regardless of how much or little government (if any) people want, they should at least be able to see and understand what it is up to and how much it costs them personally. In every way OPR flouts this principle. The law’s 2,700 pages of impenetrable “English” was read in its entirety by few if anyone. But that only begins to describe the offense. The law leaves much to be defined in the future by government departments, boards, and commissions. Hundreds of rules and regulations have yet to be written – and who do you think will be right there offering counsel as the new insurance rules are formulated? The same insurance companies whom last week were said to be the devil incarnate. (And Organized Medicine and Big Pharma too.) That’s how the Washington game is played. And we’re the losers.
I agree,organized medicine (at least the AMA and ACP) were on hand to "offer council" but while Pharma may have made out OK ( I say" may" because all of the fall out has not begun to fall ) organized medicine,IMHO, didn't get much to show for their lobbying efforts.The small dollops to physicians are more illusory than real and a very small price to approve giving massive power to the Secretary of HHS.
Wednesday, March 31, 2010
Compulsory medical insurance -but not until after the next presidential election
Front load some of the benefits, back load the costs and the compulsions, put them all together in a behemoth sized bill of mind boggling complexity and ambiguity and voila you have health care reform reform passed with 2 or 3 votes to spare. Here is cogent discussion of why the bill is so long and so complex when a few pages could have described a plan to give subsidies to those too poor to purchase health insurance. Could it be more than just a health care bill?
Apparently Senator Baucus thinks the health care bill may serve at least other or perhaps more important purpose.See here for that story. Here is what he is quoted as saying:
"Too often, much of late, the last couple three years, the mal-distribution of income in American is gone up way too much, the wealthy are getting way, way too wealthy and the middle income class is left behind," "Wages have not kept up with increased income of the highest income in America. This legislation will have the effect of addressing that mal-distribution of income in America."
Vice-President, Joe Biden, however says no, It is just being fair.See here
To the extent that Baucus has corrected characterized the legislation there are those who would believe that social justice has been well served as it is always said to be when wealth is redistributed.To those folks I submit the following commentary by the economist D.W.MacKensie
While we cannot be sure about the details of future changes in government regulations or programs, economic theory indicates that these costs rise over time. Ideally, legislators pursue what some people term ‘social justice’ through redistribution. The term social justice lacks any objective meaning. People have different opinions as to what constitutes a fair redistribution of wealth, and there is no objective criterion for determining whose version of social justice is correct. No one can comprehend all the factors that would have to enter into an actual estimate of ‘socially just’ income distribution. Claims of social justice are at best based on narrow and incomplete value judgments, and at worst completely arbitrary opinions. Since social justice has no meaning, the pursuit of this goal inevitably degenerates into power struggles among interest groups.
"Power struggles by special interests groups" is a concept not typically taught in high school civics class.
Apparently Senator Baucus thinks the health care bill may serve at least other or perhaps more important purpose.See here for that story. Here is what he is quoted as saying:
"Too often, much of late, the last couple three years, the mal-distribution of income in American is gone up way too much, the wealthy are getting way, way too wealthy and the middle income class is left behind," "Wages have not kept up with increased income of the highest income in America. This legislation will have the effect of addressing that mal-distribution of income in America."
Vice-President, Joe Biden, however says no, It is just being fair.See here
To the extent that Baucus has corrected characterized the legislation there are those who would believe that social justice has been well served as it is always said to be when wealth is redistributed.To those folks I submit the following commentary by the economist D.W.MacKensie
While we cannot be sure about the details of future changes in government regulations or programs, economic theory indicates that these costs rise over time. Ideally, legislators pursue what some people term ‘social justice’ through redistribution. The term social justice lacks any objective meaning. People have different opinions as to what constitutes a fair redistribution of wealth, and there is no objective criterion for determining whose version of social justice is correct. No one can comprehend all the factors that would have to enter into an actual estimate of ‘socially just’ income distribution. Claims of social justice are at best based on narrow and incomplete value judgments, and at worst completely arbitrary opinions. Since social justice has no meaning, the pursuit of this goal inevitably degenerates into power struggles among interest groups.
"Power struggles by special interests groups" is a concept not typically taught in high school civics class.
Sunday, March 28, 2010
As business realize Obamacare will cost them,congress will demand what?
Henry Waxman appears angry (see here ) that CEOs of corporations dare tell the public that they will loose money from Obamacare and will haul them before tv cameras in a hearing room and ...
I suppose he might challenge them saying that how dare they know more about their own financial bottom line that the policy wonks who allege great savings for all.Surely folks who run businesses do not know more about their business than a government staffer who knows little or none of the particulars of the costs and other elements of a given business enterprise. It just gets better and better.
I suppose he might challenge them saying that how dare they know more about their own financial bottom line that the policy wonks who allege great savings for all.Surely folks who run businesses do not know more about their business than a government staffer who knows little or none of the particulars of the costs and other elements of a given business enterprise. It just gets better and better.
at least one country does its part for the earth and celebrates earth hour every night
Wednesday, March 17, 2010
So who will do well and who will not as the Medical Care "reform" is enacted
A recent poll of U.S. physicians was published in the NEJM,(see here).About 46% of primary care physicians indicated they would leave practice or at least seriously consider leaving practice if some version the Senate health care bill becomes law.
The law will increase the number of patients covered under Medicaid and if big cuts occur in the Medicare Advantage there will be an increase in the number of folks moving to regular Medicare.We will have a situation in which there will be more patients trying to obtain care from fewer physicians. Those physicians remaining in the Medicare/Medicare treating group will be faced with increasing regulations and controls and ultimately further decreases in payments as the approximately $500 million in projected "savings" in Medicare payments play out. This in turn is likely to spral down with more physicians "going Galt".
Waiting lists , shortages and decreased quality likely will result. In Massachusetts with its version of what is to come nationally there are much longer wait times for physician visits even in spite of the very high per capita number of docs in that state.
Having health insurance is not equivalent to receiving health care. Who typically gets the goods or services that are in short supply due to government controls, the well to-do and well connected or the poor and less well connected? Either through accessing retainer practices ( it will take a while to outlaw them) or other means of getting to the front of the line or getting care out of the country the richer and more connected will , as always do much better. Those who will not are some the same folks who are the alleged beneficiaries of this deconstruction/reconstruction of health care.
The law will increase the number of patients covered under Medicaid and if big cuts occur in the Medicare Advantage there will be an increase in the number of folks moving to regular Medicare.We will have a situation in which there will be more patients trying to obtain care from fewer physicians. Those physicians remaining in the Medicare/Medicare treating group will be faced with increasing regulations and controls and ultimately further decreases in payments as the approximately $500 million in projected "savings" in Medicare payments play out. This in turn is likely to spral down with more physicians "going Galt".
Waiting lists , shortages and decreased quality likely will result. In Massachusetts with its version of what is to come nationally there are much longer wait times for physician visits even in spite of the very high per capita number of docs in that state.
Having health insurance is not equivalent to receiving health care. Who typically gets the goods or services that are in short supply due to government controls, the well to-do and well connected or the poor and less well connected? Either through accessing retainer practices ( it will take a while to outlaw them) or other means of getting to the front of the line or getting care out of the country the richer and more connected will , as always do much better. Those who will not are some the same folks who are the alleged beneficiaries of this deconstruction/reconstruction of health care.
Sunday, March 07, 2010
Just a few reasons why meta-analysis may sometimes not advance our knowledge or understanding
Dr. David Rind in his blog "Evidence in Medicine" tackles an issue that has bothered me for some time.See here.That issue is, in the form of a question, is " are meta-analyses (MAs) really helpful" or not. I have questioned whether MAs should sit as high as they do on the generally accepted hierarchy of evidence based medicine. See here for my overly lengthy comments on why MA should not share the pinnacle position on the evidence based medicine hierarchy with randomized clinical trials and why the hierarchy scheme itself is flawed.
In his commentary he lists some of the reasons why they may be neither helpful nor productive of new insights. He is not saying MAs are never helpful ( and neither am I) and in fact takes the position that a recent MA regarding statins and diabetes does provide useful information .
Why may MAs sometimes not be very useful. Here are some of the reasons Rind lists and some others:
From Dr. Rind's commentary
1) Frequently... meta-analyses are either driven by the single large RCT that everyone would have cited anyway or, worse, a number of small, poorly-performed RCTs are combined with a moderate-sized, well-performed RCT and alter the results away from what was likely the best estimate of reality: the results of the well-performed RCT.
Sculpturing the numbers from several small, poorly done RCTs is no guarantee of discovering the clinical truth and may well give credence to some bad ideas.
3.MAs authored by folks with little or not subject matter expertise cannot or do not put the issues in a context that would have born of actual experience.
4.MAs that lump apples and peaches. I am reminded of one MA that looked at all thrombolytics. You don't write an order for "a thrombolytic" you write for a specific one.
5.Remembering that a meta-analysis is really an observational study in which the observed entities are trials,there is a real risk that the investigators might pre-screen the trails and in a post hoc fashion devise inclusion or exclusion criteria that would stack the deck to favor a conclusion that they already "knew was right".
In his commentary he lists some of the reasons why they may be neither helpful nor productive of new insights. He is not saying MAs are never helpful ( and neither am I) and in fact takes the position that a recent MA regarding statins and diabetes does provide useful information .
Why may MAs sometimes not be very useful. Here are some of the reasons Rind lists and some others:
From Dr. Rind's commentary
1) Frequently... meta-analyses are either driven by the single large RCT that everyone would have cited anyway or, worse, a number of small, poorly-performed RCTs are combined with a moderate-sized, well-performed RCT and alter the results away from what was likely the best estimate of reality: the results of the well-performed RCT.
Sculpturing the numbers from several small, poorly done RCTs is no guarantee of discovering the clinical truth and may well give credence to some bad ideas.
3.MAs authored by folks with little or not subject matter expertise cannot or do not put the issues in a context that would have born of actual experience.
4.MAs that lump apples and peaches. I am reminded of one MA that looked at all thrombolytics. You don't write an order for "a thrombolytic" you write for a specific one.
5.Remembering that a meta-analysis is really an observational study in which the observed entities are trials,there is a real risk that the investigators might pre-screen the trails and in a post hoc fashion devise inclusion or exclusion criteria that would stack the deck to favor a conclusion that they already "knew was right".
Friday, February 26, 2010
So far carotid endarterectomy looks better than carotid stenting
"So far" here means according to the results of the interim analysis of the International Carotid Stenting Study (ICSS) surgery looks better. This trial has enrolled 1713 with symptomatic carotid artery stenosis to either endarterectomy or stenting with the major outcome of interest to be the three year outcome of fatal or disabling stroke.
The interim analysis focused on the 3 month comparison of the rate of stroke,death and procedural myocardial infarction in the two groups.The endarterectomy group experienced 27 such events versus 34 in the stenting group or 8.5 % versus 5.2%.
The authors offered this closing sentence:
Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
A earlier trial ( see here) in France also demonstrated the apparent superiority of surgery over carotid stenting.This was the EVa-3s trial which was stopped early for reasons of futility and safety.
For what it is worth the latest Medical Knowledge Self-Assessment Program MKSAP 15 says this about symptomatic ,severe (greater than 70%), carotid artery stenosis:
"carotid endarterectomy is still considered the gold standard..". (One may wonder why a retired internist is still ordering and reading MKSAP)
If I had to decide today in regard to my own neck I would opt for surgery .Of course, I live in an area populated with a large number of excellent, well experienced vascular surgeons and hospitals in which a lot of vascular surgery is performed.
ADDENDUM: (2/26/2010 1:00pm CST)
On the other hand maybe things might be a bit different in North American.The CREST trial results were just reported and seemingly stenting fares better but still not better than endarterectomy overall. Are American stentists more adept? Is comparative effectiveness research (CER) easy or what?
The interim analysis focused on the 3 month comparison of the rate of stroke,death and procedural myocardial infarction in the two groups.The endarterectomy group experienced 27 such events versus 34 in the stenting group or 8.5 % versus 5.2%.
The authors offered this closing sentence:
Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
A earlier trial ( see here) in France also demonstrated the apparent superiority of surgery over carotid stenting.This was the EVa-3s trial which was stopped early for reasons of futility and safety.
For what it is worth the latest Medical Knowledge Self-Assessment Program MKSAP 15 says this about symptomatic ,severe (greater than 70%), carotid artery stenosis:
"carotid endarterectomy is still considered the gold standard..". (One may wonder why a retired internist is still ordering and reading MKSAP)
If I had to decide today in regard to my own neck I would opt for surgery .Of course, I live in an area populated with a large number of excellent, well experienced vascular surgeons and hospitals in which a lot of vascular surgery is performed.
ADDENDUM: (2/26/2010 1:00pm CST)
On the other hand maybe things might be a bit different in North American.The CREST trial results were just reported and seemingly stenting fares better but still not better than endarterectomy overall. Are American stentists more adept? Is comparative effectiveness research (CER) easy or what?
Tuesday, February 23, 2010
Why is the Avandia issue being raised again?
Dr.Mintz offers a good re-review of the literature behind the controversy regarding rosiglitazone (Avandia).
Avandia has been in the news again. See here. Dr. Mnitz says there is nothing new regarding data accumulation or analysis. So why are we hearing about it again. Why are Senators Grassley and Baucus stirring the pot again?
Any thoughts?
Avandia has been in the news again. See here. Dr. Mnitz says there is nothing new regarding data accumulation or analysis. So why are we hearing about it again. Why are Senators Grassley and Baucus stirring the pot again?
Any thoughts?
Sunday, February 14, 2010
If medical care costs "too much" easy fix is price controls?
The Massachusetts health care plan facing costs greatly in excess of previously advertised ( fantasied?) cost projections can be fixed, according to a proposal by the governor of Mass. The answer is government controlled prices.See here for a new report on that development.
Wage and price controls predictably leads to several things:
poor quality, shortages and black markets.
The Medicare price controls have lead to the first two in regard to primary care.See here for an earlier rant on how price controls has worked out in regard to Medicare.
Wage and price controls predictably leads to several things:
poor quality, shortages and black markets.
The Medicare price controls have lead to the first two in regard to primary care.See here for an earlier rant on how price controls has worked out in regard to Medicare.
Thursday, February 11, 2010
Statins in drinking water? not quite yet, but CRP for lots of folks?
The JUPITER trial was a great boost for Crestor and the use of the hs CRP and now the FDA gives approval for wider use of at least one statin.See here for FDA information. Dr. Mintz,as is often the case, offers his thoughtful insights to this issue here.
It has been a while since JUPITER was completed so if you want a review and a very detailed discussion of many of the related issues go here to read what DrRich had to say.
I will shamelessly repeat what I wrote earlier:
"You can talk about the fact that Jupiter was terminated prematurely, you can talk about relative risk versus absolute risk reduction and Crestor effect versus class effect but in the end here is the way things seems to work. When you have a large randomized clinical trial that demonstrates a benefit for a given medication and when many well known medical thought leaders endorse it and when it is then approved by the FDA you know that guidelines will be written and quality rule driven medical practitioners will follow and many patients will take the medication and likely insurance companies will pay for some or all of it.So in this case many folks will have their hs-crp checked and they will be prescribed Crestor ( a few will be given lower price statin cousins) and there will be- for a while- talk about crp at parties."
It has been a while since JUPITER was completed so if you want a review and a very detailed discussion of many of the related issues go here to read what DrRich had to say.
I will shamelessly repeat what I wrote earlier:
"You can talk about the fact that Jupiter was terminated prematurely, you can talk about relative risk versus absolute risk reduction and Crestor effect versus class effect but in the end here is the way things seems to work. When you have a large randomized clinical trial that demonstrates a benefit for a given medication and when many well known medical thought leaders endorse it and when it is then approved by the FDA you know that guidelines will be written and quality rule driven medical practitioners will follow and many patients will take the medication and likely insurance companies will pay for some or all of it.So in this case many folks will have their hs-crp checked and they will be prescribed Crestor ( a few will be given lower price statin cousins) and there will be- for a while- talk about crp at parties."
Tuesday, January 26, 2010
Enactment of Comparative Effectiveness Research -Libertarian Parternalism or Orszag type coercion
An excellent commentary by Dr. Jerome Groopman can be found here . It which offers a very thoughtful analysis of a number of issues related to comparative effectiveness research (CER) and what comes next.
He tells a narrative of two highly placed Obama administration players who views are seemingly widely divergent in regard to how to implement findings from clinical research; Cass Sunstein and Peter Orszag.
Sustein would "nudge" us along to do what is best for us while Orszag would implement, for example, the findings of comparative effectiveness research (CER) with " aggressive promulgation of standards and changes in financial and other incentives", the later approach finding a statutory home in the Senate health care bill but not the House bill.
Sustein and his collaborator Richard Thaler have brought to the current trendy universe of discourse and commentary the notion of "libertarian paternalism" (LP) replete with the concept of "Choice architect" and "nudging folks" to make the right decision in areas wherein their ignorance, cognitive limitations and lack of will power cloud their minds so that they do not do what in the view of the architects is the action which really is in their best interests. Basically the LP camp seems to say we ( the experts ) know what is best for you and we will in various not- really- coercive ways gently push you in the right direction. The more traditional progressive view, as exemplified by Orszag, is we know what is right and we,if necessary, will summon the force of law to make you do it.
Groopman favors the LP view and adduces persuasive evidence to the argument that a number of the so-called best practices and quality measures have been simply very bad ideas with bad consequences and I would add monuments to the hypertrophied hubris of those architects.These fiascoes include the now notorious 4 hour rule for pneumonia,fountain of youth estrogen movement,very tight blood sugar control for critically ill patients, and relatively tight glucose control for ambulatory patients,statins for dialysis patients and I would add:beta blockers for almost everyone pre op.Other quality measures have been shown to have no effect one way or the other.
Goopman, in a David Hume-like argument, turns the notion of the cognitive biases that limit the non-expert humans back on the experts pointing out the obvious that they too may fall victim to the same biases, such as overconfidence, the focusing illusion and confirmation bias and that they tend to " overestimate [their] ability to analyze information, make accurate estimates and project outcomes". He even admits that he was subject to some of those foibles in what turned out to be an over-zealous push for Erythropoiesis-stimulating agents, in cancer patients.
Dr. Goopman then offers what I believe is a profound insight in regard to expert panel's "best practices".They may often fail to recognize and distinguish between those practices that can be standardized and not significantly altered by the particulars of the individual patient and those that those practices that must be altered to the individual patient. A check list to prevent infection when an IV catheter is inserted exemplifies the former and issuing a dictum that all ambulatory patients with diabetes should be treated to a given Hb AIc is an example of the latter.What blood sugar target level is optimal may vary not only between individual patients but also may vary often time with the same patient and the one size for everyone is a recipe for trouble.
To the extent they actually believe their own rhetoric both Obama and Orszag demonstrate a naive view of science and medical research. They speak of simply "finding out what works and what doesn't" seemingly ignorant of the fact that so often what we "determine" today from clinical research is contradicted tomorrow and how very difficult it can be to find out what is best or even define "best"Science offers provisional conclusions subject to refutation.It is often not a matter of what works and what does not but more often a trade off between various approaches each with its own set of benefits and dangers.
Dr. Groopman hopes that the Sunstein approach will be used- preferring nudging to coercion. Given a binary choice I would opt for nudging as well However, some have suggested that notion of libertarian paternalism is an oxymoron and some have raised a slippery slope concern see here for one discussion of those issues.Nudging might gradually morph into regular traditional coercive paternalism. I am reminded of the "third party experts" who profess to know what is best for you better than you do and Thomas Sowell's comments in that regard.See here to see and hear Sowell on that issue.
He tells a narrative of two highly placed Obama administration players who views are seemingly widely divergent in regard to how to implement findings from clinical research; Cass Sunstein and Peter Orszag.
Sustein would "nudge" us along to do what is best for us while Orszag would implement, for example, the findings of comparative effectiveness research (CER) with " aggressive promulgation of standards and changes in financial and other incentives", the later approach finding a statutory home in the Senate health care bill but not the House bill.
Sustein and his collaborator Richard Thaler have brought to the current trendy universe of discourse and commentary the notion of "libertarian paternalism" (LP) replete with the concept of "Choice architect" and "nudging folks" to make the right decision in areas wherein their ignorance, cognitive limitations and lack of will power cloud their minds so that they do not do what in the view of the architects is the action which really is in their best interests. Basically the LP camp seems to say we ( the experts ) know what is best for you and we will in various not- really- coercive ways gently push you in the right direction. The more traditional progressive view, as exemplified by Orszag, is we know what is right and we,if necessary, will summon the force of law to make you do it.
Groopman favors the LP view and adduces persuasive evidence to the argument that a number of the so-called best practices and quality measures have been simply very bad ideas with bad consequences and I would add monuments to the hypertrophied hubris of those architects.These fiascoes include the now notorious 4 hour rule for pneumonia,fountain of youth estrogen movement,very tight blood sugar control for critically ill patients, and relatively tight glucose control for ambulatory patients,statins for dialysis patients and I would add:beta blockers for almost everyone pre op.Other quality measures have been shown to have no effect one way or the other.
Goopman, in a David Hume-like argument, turns the notion of the cognitive biases that limit the non-expert humans back on the experts pointing out the obvious that they too may fall victim to the same biases, such as overconfidence, the focusing illusion and confirmation bias and that they tend to " overestimate [their] ability to analyze information, make accurate estimates and project outcomes". He even admits that he was subject to some of those foibles in what turned out to be an over-zealous push for Erythropoiesis-stimulating agents, in cancer patients.
Dr. Goopman then offers what I believe is a profound insight in regard to expert panel's "best practices".They may often fail to recognize and distinguish between those practices that can be standardized and not significantly altered by the particulars of the individual patient and those that those practices that must be altered to the individual patient. A check list to prevent infection when an IV catheter is inserted exemplifies the former and issuing a dictum that all ambulatory patients with diabetes should be treated to a given Hb AIc is an example of the latter.What blood sugar target level is optimal may vary not only between individual patients but also may vary often time with the same patient and the one size for everyone is a recipe for trouble.
To the extent they actually believe their own rhetoric both Obama and Orszag demonstrate a naive view of science and medical research. They speak of simply "finding out what works and what doesn't" seemingly ignorant of the fact that so often what we "determine" today from clinical research is contradicted tomorrow and how very difficult it can be to find out what is best or even define "best"Science offers provisional conclusions subject to refutation.It is often not a matter of what works and what does not but more often a trade off between various approaches each with its own set of benefits and dangers.
Dr. Groopman hopes that the Sunstein approach will be used- preferring nudging to coercion. Given a binary choice I would opt for nudging as well However, some have suggested that notion of libertarian paternalism is an oxymoron and some have raised a slippery slope concern see here for one discussion of those issues.Nudging might gradually morph into regular traditional coercive paternalism. I am reminded of the "third party experts" who profess to know what is best for you better than you do and Thomas Sowell's comments in that regard.See here to see and hear Sowell on that issue.
Interesting new term-"Insurance free medicine" That may be what we need.
Go here to read a very interesting and thoughtful commentary by an academic internist whose thoughts I have quoted before.Dr Matthew Mintz suggests a new term, "Insurance free medicine" which I agree is a useful way to encompass several other terms and to reference modes of medical practice that have evolved to escape the increasingly intolerable world of primary care dominated by insurance companies and CMS. Here I refer to both family practice and internal medicine. do not have enough information about current day pediatric practice to comment meaningfully in regard to the current status of that aspect of primary care.))
Insurance free medicine would cover practice arrangements that are now called the following:
concierge medicine,retainer medicine,cash only medicine and boutique medicine.
I would sign up today if I could find an internist in my area offering insurance only medicine.
Insurance free medicine would cover practice arrangements that are now called the following:
concierge medicine,retainer medicine,cash only medicine and boutique medicine.
I would sign up today if I could find an internist in my area offering insurance only medicine.
Monday, January 18, 2010
Toronto ACP meeting to offer mini-courses in minor surgery-what is that about?
I recently received a copy of the advance program for the April 2010 scientific meeting of the American College of Physicians (ACP). On page 38 we find a list of mini-courses in "Clinical Skills in Procedures". These include: skin biopsy and cryosurgery,suturing skills, and my favorite,"toenail removal" about which they state :
"Learn the indications for toenail removal. Using a realistic model and actual surgical instruments ( I guess as opposed to fake instruments),practice a digital block,wedge resection and removal of an ingrown toenail and wound care."
I am puzzled as to the intent of the ACP planners in offering this course. Do they intend that an internist whose post medical school training to my knowledge does not involve the development of surgical skills offer this procedure in his office with only several hours of instruction/practice as his qualifications? Do they believe that one serves his patient well by having an under trained physician perform a surgical procedure?
Should the planners of this course develop a painful ingrown toenail who would seek out for treatment: a general surgeon, an orthopedic foot surgeon, a podiatrist or an internist who took a course at the ACP meeting? I am reminded of this Monty Python skit of a job counseling interview in which the applicant's sole quality for lion taming was a hat that said 'Lion Tamer".
I have written before as has Dr RW (see here and here for his comments and here for mine) on what seems to me to be an identity crisis in internal medicine evidence for which is found in the more recent editions of MKSAP as well as the annual scientific meeting wherein the planners seem to be trying hard to make internists more like family practice physicians. The general internal medicine section of MKSAP had many sections removed from typical or traditional internist's training and areas of expertise such as diagnosis and treatment of corneal abrasions and detailed evaluations of uterine bleeding to name just two. A suturing skills mini-course practicing on pig's feet is part of the "why can't internists be more like family practitioners ?" movement, one that I believe does not enhance internist's patients' care nor the public or self image of internists.
"Learn the indications for toenail removal. Using a realistic model and actual surgical instruments ( I guess as opposed to fake instruments),practice a digital block,wedge resection and removal of an ingrown toenail and wound care."
I am puzzled as to the intent of the ACP planners in offering this course. Do they intend that an internist whose post medical school training to my knowledge does not involve the development of surgical skills offer this procedure in his office with only several hours of instruction/practice as his qualifications? Do they believe that one serves his patient well by having an under trained physician perform a surgical procedure?
Should the planners of this course develop a painful ingrown toenail who would seek out for treatment: a general surgeon, an orthopedic foot surgeon, a podiatrist or an internist who took a course at the ACP meeting? I am reminded of this Monty Python skit of a job counseling interview in which the applicant's sole quality for lion taming was a hat that said 'Lion Tamer".
I have written before as has Dr RW (see here and here for his comments and here for mine) on what seems to me to be an identity crisis in internal medicine evidence for which is found in the more recent editions of MKSAP as well as the annual scientific meeting wherein the planners seem to be trying hard to make internists more like family practice physicians. The general internal medicine section of MKSAP had many sections removed from typical or traditional internist's training and areas of expertise such as diagnosis and treatment of corneal abrasions and detailed evaluations of uterine bleeding to name just two. A suturing skills mini-course practicing on pig's feet is part of the "why can't internists be more like family practitioners ?" movement, one that I believe does not enhance internist's patients' care nor the public or self image of internists.
Thursday, January 07, 2010
If Mayo Clinic loses money on Medicare , what will the "average" internist do?
While the AMA and the ACP seemingly see better things ahead ( I assume they do because of their support for a bill whose particulars still remain a secret) after passage of the final health insurance deconstruction-reconstruction bill, the prestigious Mayo Clinic has seen fit to restrict Medicare patients because they loose money on their care.
Mayo's primary care physicians will only see Medicare patients at its Arizona facility if they agree to pay a $ 1500 annual fee. The Rochester mother ship facility has announced it will see Medicaid patients only from certain states.
Dr. Toni Brayer, author of the blog Everythinghealth, in her Jan 6,2010 on line issue of the ACP Internist tells her readers she has the same problem.Because of other sources of income she plans to continues to care for her Medicare patients but how many other internists will continue to choose to eat that economic loss. How many can afford to?
According to Dr. Brayer, Mayo clinic looses $ 840 million on Medicare patients' care and that about 70% of hospitals loose money on Medicare patients.
The issue is much bigger than Mayo's decision. Many physicians are not accepting new Medicare patients. The Texas Medical Association has reported that their survey of primary care physician indicates only 38% of Texas primary care docs are accepting new Medicare patients.
The incredibly arrogant purposeful secrecy and what has been described as "cash for caucus" of what the legislative process has descended to, makes it impossible to know what is planned to alleviate the problem of primary care docs not being financially able to treat Medicare patients. I share Dr. Wes's indignation at the failure of the leadership of major medical organizations when he states:
We see this as our professional membership leaders failed to ask about the details of the health bills ( my bolding) before them nor inquired about the potential flaws inherent to comparative effectiveness research promulgated on large, unfiltered populations. Rather, our representatives capitulated and mollified themselves with platitudes.
Here is what a recent commentary in the Boston Globe said in regard to the growing disconnect between primary care physician and Medicare-Medicaid patients and the Senate health bill;
The Centers for Medicare and Medicaid Services, a branch of the US Department of Health and Human Services, estimated last month that the Senate bill would squeeze $493 billion out of Medicare over the next 10 years. As a result, it cautioned, “providers for whom Medicare constitutes a substantive portion of their business could find it difficult to remain profitable and . . . might end their participation in the program (possibly jeopardizing access to care for beneficiaries).’’ In short, the Democratic understanding of health care reform - more government power to set prices, combined with reduced freedom for individuals - will make medical care harder to come by: an Economics 101 lesson in the pitfalls of price controls.
With many millions ( no, Virginia there will not be "universal coverage, still about 23 million will not be insured) more added to the medically insured population, with no meaningful relief in the wage-price controls on physician's fees from CMS and numerous hints in the bills of a heavier and more obtuse administration thumb on medical care details it seems inevitable that more and more physicians, unlike Dr. Brayer, will just shrug.
Mayo's primary care physicians will only see Medicare patients at its Arizona facility if they agree to pay a $ 1500 annual fee. The Rochester mother ship facility has announced it will see Medicaid patients only from certain states.
Dr. Toni Brayer, author of the blog Everythinghealth, in her Jan 6,2010 on line issue of the ACP Internist tells her readers she has the same problem.Because of other sources of income she plans to continues to care for her Medicare patients but how many other internists will continue to choose to eat that economic loss. How many can afford to?
According to Dr. Brayer, Mayo clinic looses $ 840 million on Medicare patients' care and that about 70% of hospitals loose money on Medicare patients.
The issue is much bigger than Mayo's decision. Many physicians are not accepting new Medicare patients. The Texas Medical Association has reported that their survey of primary care physician indicates only 38% of Texas primary care docs are accepting new Medicare patients.
The incredibly arrogant purposeful secrecy and what has been described as "cash for caucus" of what the legislative process has descended to, makes it impossible to know what is planned to alleviate the problem of primary care docs not being financially able to treat Medicare patients. I share Dr. Wes's indignation at the failure of the leadership of major medical organizations when he states:
We see this as our professional membership leaders failed to ask about the details of the health bills ( my bolding) before them nor inquired about the potential flaws inherent to comparative effectiveness research promulgated on large, unfiltered populations. Rather, our representatives capitulated and mollified themselves with platitudes.
Here is what a recent commentary in the Boston Globe said in regard to the growing disconnect between primary care physician and Medicare-Medicaid patients and the Senate health bill;
The Centers for Medicare and Medicaid Services, a branch of the US Department of Health and Human Services, estimated last month that the Senate bill would squeeze $493 billion out of Medicare over the next 10 years. As a result, it cautioned, “providers for whom Medicare constitutes a substantive portion of their business could find it difficult to remain profitable and . . . might end their participation in the program (possibly jeopardizing access to care for beneficiaries).’’ In short, the Democratic understanding of health care reform - more government power to set prices, combined with reduced freedom for individuals - will make medical care harder to come by: an Economics 101 lesson in the pitfalls of price controls.
With many millions ( no, Virginia there will not be "universal coverage, still about 23 million will not be insured) more added to the medically insured population, with no meaningful relief in the wage-price controls on physician's fees from CMS and numerous hints in the bills of a heavier and more obtuse administration thumb on medical care details it seems inevitable that more and more physicians, unlike Dr. Brayer, will just shrug.
Tuesday, January 05, 2010
Why does the AMA support senate and House health insurance bills?
Several blogs have taken up the issue of the AMA 's support of the health insurance bills currently sliding behind the scenes through Congress. Here is a newspaper article that makes the case for a theme that is found in a number of blogs.
Essentially the charge is that the AMA supports the bill because of the fees it receives for what is described as a monopoly of the insurance billing codes (the CPT codes ). Linda Gorman explains it here.
Apparently HCFA and the AMA reached an agreement with the AMA to use AMA's copyrighted CPT Codes (Current Procedural Terminology codes) for Medicare billing purposes. AMA does not report income from their CPT business separately but estimates suggest something in the range of $ 70 million per year,not a large number by today's standards but significantly more than AMA receives from dues. (Only about 15% of physicians now belong to AMA)
The 1983 HCFA-AMA pact originally precluded the use of other codes for purposes of physician outpatient fees for Medicare and Medicaid.A 1997 Ninth Circuit finding that the AMA was misusing a copyright lliminated the exclusivity but by that time the CPT was the industry standard.
Dr. J.J. Rohack had this to say in reply to Gorman's commentary :
This democratic forum of grassroots physicians and medical students directed the AMA in 1983 to have Reagan Administration recognize CPT as the standard for physician coding. At the time, physicians struggled to cope with the multiple code sets used by third party payers, including the government. AMA brought calm to this chaos by securing a physician-driven standard used to describe medical services.
SERMO, the online physician social network, has become very critical of AMA's role in CPT and in fact has severed an earlier working agreement with AMA. See here for comments from SERMO's founder, Dr. Daniel Palestrant.
The AMA has received CPT fees for a number of years, why now have they reversed earlier opposition to universal health care plans? What exactly is the alleged link between the two? I do not claim the two are not related but I am having trouble seeing exactly how that works. I ask my handful of readers for their input.
Essentially the charge is that the AMA supports the bill because of the fees it receives for what is described as a monopoly of the insurance billing codes (the CPT codes ). Linda Gorman explains it here.
Apparently HCFA and the AMA reached an agreement with the AMA to use AMA's copyrighted CPT Codes (Current Procedural Terminology codes) for Medicare billing purposes. AMA does not report income from their CPT business separately but estimates suggest something in the range of $ 70 million per year,not a large number by today's standards but significantly more than AMA receives from dues. (Only about 15% of physicians now belong to AMA)
The 1983 HCFA-AMA pact originally precluded the use of other codes for purposes of physician outpatient fees for Medicare and Medicaid.A 1997 Ninth Circuit finding that the AMA was misusing a copyright lliminated the exclusivity but by that time the CPT was the industry standard.
Dr. J.J. Rohack had this to say in reply to Gorman's commentary :
This democratic forum of grassroots physicians and medical students directed the AMA in 1983 to have Reagan Administration recognize CPT as the standard for physician coding. At the time, physicians struggled to cope with the multiple code sets used by third party payers, including the government. AMA brought calm to this chaos by securing a physician-driven standard used to describe medical services.
SERMO, the online physician social network, has become very critical of AMA's role in CPT and in fact has severed an earlier working agreement with AMA. See here for comments from SERMO's founder, Dr. Daniel Palestrant.
The AMA has received CPT fees for a number of years, why now have they reversed earlier opposition to universal health care plans? What exactly is the alleged link between the two? I do not claim the two are not related but I am having trouble seeing exactly how that works. I ask my handful of readers for their input.
Wednesday, December 30, 2009
More counterpoints to the Dartmouth Atlas data
This article from the journal Circulation provides data and analysis that at least suggests that the sweeping conclusions of the Dartmouth group may not tell all of the story. h/t to this entry by the Buckeye Surgeon.
The widely quoted publications of the Dartmouth group that studied the regional variations in Medicare patient death rates have been condensed to a simple recipe to solve at least some of the country's medical problems-let's all be more like the Mayo Clinic and the implication that spending more money necessarily translates into poorer health care.
The Circulation studied looked at the outcomes of Medicare patients in 6 California teaching hospitals.Here is the conclusion of the study's authors:
Conclusions— California teaching hospitals that used more resources caring for patients hospitalized for heart failure had lower mortality rates. Focusing only on expired individuals may overlook mortality variation as well as associations between greater resource use and lower mortality. Reporting values without identifying significant differences may result in incorrect assumption of true differences.
It is only in the context of the hype generated with the Dartmouth studies that one would be surprised that spending more resources on sick patients might actually improve their outcome.It is obviously true at the extreme-if we spend no money at all good outcomes would be unlikely. Within some of the health care "reform" rhetoric we hear the theme that spending more money is necessarily bad and wasteful. Spending more can be wasteful but often it is not. It is an empirical question and very context dependent- not one determined by reference to first principles.
I have written before abut Dr. Richard Cooper's critique and criticism of the Atlas studies.See here for some details of Dr. Cooper's arguments and comments by the economist, Arnold Kling.
Tuesday, December 29, 2009
Will long term endurance exercise prevent your telomeres from shortening?
I hope so and here is some evidence suggesting long term endurance exercise may mitigate the aging process which is part seems to be due to one's "chromosomes shortening". I had written earlier about claims that vitamin D has a similar effect.
This is not the first such article making this type association. This article by La Rocca et al in Circulation demonstrated longer leukocyte telomere length (LTL) in older endurance exercisers and correlated LTL with aerobic capacity and an index of endothelial dilatation.
An interesting study published in the Archive of Internal Medicine which in part involved study of twins showed that the inactive twin had shorter telomeres that the more active sibling. A companion editorial offered the appropriate caveats which might serve to mitigate any undue exuberance forthcoming from overly smug ,older long time runners:
A great deal of research has been done on telomere length in the past few years, and exactly what it is telling us is still being argued. Cross-sectional studies show that telomeres in humans are shorter at older ages and telomere length is shorter in peripheral white blood cells in a variety of chronic diseases. However, although shorter telomere length has been associated with cell senescence, its direct effect on organ function is not well documented, and telomere length in postmitotic cells has not been related to life span in the experimental animal in which it has been extensively studied, Caenorhabditis elegans.
Yeah, I know you shouldn't get carried away by surrogate makers. Further, this study of older Chinese found no such relationship.
So, I continue to run as long as I can even if the effect on telomeres really means little or nothing because after each run I seem reassured that I am not really that old yet (the marked reduction in running speed notwithstanding) as irrational as that belief is.
This is not the first such article making this type association. This article by La Rocca et al in Circulation demonstrated longer leukocyte telomere length (LTL) in older endurance exercisers and correlated LTL with aerobic capacity and an index of endothelial dilatation.
An interesting study published in the Archive of Internal Medicine which in part involved study of twins showed that the inactive twin had shorter telomeres that the more active sibling. A companion editorial offered the appropriate caveats which might serve to mitigate any undue exuberance forthcoming from overly smug ,older long time runners:
A great deal of research has been done on telomere length in the past few years, and exactly what it is telling us is still being argued. Cross-sectional studies show that telomeres in humans are shorter at older ages and telomere length is shorter in peripheral white blood cells in a variety of chronic diseases. However, although shorter telomere length has been associated with cell senescence, its direct effect on organ function is not well documented, and telomere length in postmitotic cells has not been related to life span in the experimental animal in which it has been extensively studied, Caenorhabditis elegans.
Yeah, I know you shouldn't get carried away by surrogate makers. Further, this study of older Chinese found no such relationship.
So, I continue to run as long as I can even if the effect on telomeres really means little or nothing because after each run I seem reassured that I am not really that old yet (the marked reduction in running speed notwithstanding) as irrational as that belief is.
Monday, December 28, 2009
Is everyone talking about the same health care bill?
Apparently John Goodman on one hand and the American Medical Association and the American College of Physicians on the other are interpreting the thousand of pages of almost impossible to decipher verbiage in vastly different ways.
Here is what Dr. Goodman thinks is the key "accomplishment" of the bill.See here for his entire posting and consider the reasons he lists as to why the nationalizing of health insurance is what it is all about.
Here is what Dr. Goodman thinks is the key "accomplishment" of the bill.See here for his entire posting and consider the reasons he lists as to why the nationalizing of health insurance is what it is all about.
Nationalizing health insurance. For the first time ever, the federal government will tell you what kind of insurance you must buy and (effectively) where you will buy it and what price you will pay. You will not be allowed to buy better, cheaper insurance that is more suitable for your and your family’s needs — even if an insurer is willing in principle to sell it to you.
Don’t underestimate the importance of this accomplishment. Nationalization is the abiding, overriding, everlasting, immutable, unending, permanent, unchanging goal of the political left. There is no other there, there. There is no other beef. All else is sound and fury signifying things that are way down the priority list.
Nationalizing the health insurance industry will also politicize it.With the shameless performance of the Senators and the bribes involved in the health care bill passage fresh on our minds, that is a frightening thought.Thursday, December 24, 2009
It seems very likely than warfarin's days are numbered
The oral, direct thrombin inhibitor, ximilagatran for a while seemed to be poised to be the replacement for warfarin. Early trials indicated its efficacy and safety (at least in terms of bleeding risks) but its further advancement was stymied and ultimately blocked by the observation of what proven to be a unacceptably high level of abnormal liver function test abnormalities.(Direct thrombin inhibitors (DTIs) block thrombin from cleaving fibrinogen to fibrin.)
However, its descendant, dabigatran has successfully made its way through two large randomized clinical trials and seems to be at least as efficacious and at least as safe (in terms of bleeding risks at and no major signals of other adverse effects) and will probably emerge as the long sought after replacement to warfarin.
First dabigatran looked good (in some outcomes better than warfarin and in others, "not inferior") in the RELY trial which studied its use in high risk patients with atrial fibrillation. Next the RE-COVER trial (this is not to be confused with the RECOVER (without the hyphen) trial) compared dabigatran with warfarin in patients with deep vein thrombosis and found similar good results.
So far,dabigatran seems as efficacious and safe as warfarin in atrial fibrillation and in DVT and does not require frequent blood test monitoring nor frequent dose adjustments.
Still there are concerns and questions. Dabigatran is given twice a day so the compliance issue has to be considered. Further,in RELY two doses were tested. At the 150 mg twice a there were fewer strokes so that dose seems more efficacious. At the 110 mg dose there were fewer instance of hemorrhage, so the lower dose seem safer. The 150 mg twice a day dose was used in the RE-COVER dvt trial so that dose may become the one generally used.
Dabigatran is approved in the EU for prophylaxis in total hip and total knee replacements and also in Canada.
2010 will probably see its approval in the U.S, fifty years or more after warfarin was approved.
However, its descendant, dabigatran has successfully made its way through two large randomized clinical trials and seems to be at least as efficacious and at least as safe (in terms of bleeding risks at and no major signals of other adverse effects) and will probably emerge as the long sought after replacement to warfarin.
First dabigatran looked good (in some outcomes better than warfarin and in others, "not inferior") in the RELY trial which studied its use in high risk patients with atrial fibrillation. Next the RE-COVER trial (this is not to be confused with the RECOVER (without the hyphen) trial) compared dabigatran with warfarin in patients with deep vein thrombosis and found similar good results.
So far,dabigatran seems as efficacious and safe as warfarin in atrial fibrillation and in DVT and does not require frequent blood test monitoring nor frequent dose adjustments.
Still there are concerns and questions. Dabigatran is given twice a day so the compliance issue has to be considered. Further,in RELY two doses were tested. At the 150 mg twice a there were fewer strokes so that dose seems more efficacious. At the 110 mg dose there were fewer instance of hemorrhage, so the lower dose seem safer. The 150 mg twice a day dose was used in the RE-COVER dvt trial so that dose may become the one generally used.
Dabigatran is approved in the EU for prophylaxis in total hip and total knee replacements and also in Canada.
2010 will probably see its approval in the U.S, fifty years or more after warfarin was approved.
Friday, December 18, 2009
Will CRP(c-reactive protein) become a cocktail dinner conversation?
The answer to the title question is "probably yes" if the FDA concurs with the recent recommendation of its advisory committee in regard to a "new" indication for rosuvastatin (Crestor).
Dr. Matthew Mintz gives his thoughtful analysis of the panel's decision ( see here) and,in general, he seems to support the decision of the panel. The panel basically approved rosuvastatin for patients with normal LDLs and an elevated hs-CRP (high sensitivity CRP).
As has been pointed out (see here for Sandy Szwarc's detailed comments and critique on the study (Jupiter) that lead to the panel's decision) a very large number of people would be "eligible" for this new indication.I believe her comments contain several important counter-points to the avalanche of glowing comments from well known "thought leaders" that came quickly on the heels of the publication of Jupiter in the NEJM and should be read by someone before planning to check everyone's CRP and treat those eligible folks with CRPs of over 2.Although, I'll bet that the media blitz and specialty society guideline publicity that will blare forth if and when the FDA gives final approval will overwhelm any suggestion by a physician that we might give the matter a little thought before we prescribe Crestor because of an elevated CRP.
A 2009 article by Dr. Erica Spatz concluded " JUPITER’s findings have the potential to impact treatment recommendations for 20% of middle-aged to elderly adults, thus increasing the proportion of this segment of the population with an indication for statin therapy to nearly 80%."
That 80% of middle-aged and elderly should be on a statin is ,to put it mildly, mind boggling.
One comment by a FDA panel member caught my eye-that the increases of new onset diabetes in the Jupiter trial was a "class effect" meaning that all statins tend to do that. For the number of patients for whom I recommended statins I did not see fit to warn them about an increased risk of diabetes. I was not aware of any. In fact, the West of Scotland study (WOSCOPS) found a 30% reduction in the onset of new diabetes in the pravastatin treatment arm. JUPITER had reported the opposite namely that there were 3% new diabetes cases in the treatment arm versus 2.4% in the placebo group. Further, Rajpathak published a meta-analysis of six statin trials that demonstrated a slight increase if the WOSCOPS data were excluded but no difference in onset of diabetes when that data were included. ( I never did understand why they would want to exclude the Scotland study anyway but...) So, if it is a class effect it must be a rather small one and I would worry more about muscle toxicity related side effects in the newly enlarged pool of older eligible patients.
So much has been written,just in the medical blog world,that I won't try and summarize all of the gleeful announcements of a really big breakthrough or the more somber critiques. But if you read only one commentary this one by DrRich would be worthwhile.
You can talk about the fact that Jupiter was terminated prematurely, you can talk about relative risk versus absolute risk reduction and Crestor effect versus class effect but in the end here is the way things seems to work. When you have a large randomized clinical trial that demonstrates a benefit for a given medication and when many well known medical thought leaders endorse it and when it is then approved by the FDA you know that guidelines will be written and quality rule driven medical practitioners will follow and many patients will take the medication and likely insurance companies will pay for some or all of it.So in this case many folks will have their hs-crp checked and they will be prescribed Crestor ( a few will be given lower price statin cousins) and there will be- for a while- talk about crp at parties.
My first prediction for the new year: Look for a surge of CME-oid meetings and articles on the value of CRP for cardiac risk assessment and as basis for statin therapy.Yes, we have heard about CRP for quite a while but soon we will probably have the blessing of the FDA and things will really take off.
Dr. Matthew Mintz gives his thoughtful analysis of the panel's decision ( see here) and,in general, he seems to support the decision of the panel. The panel basically approved rosuvastatin for patients with normal LDLs and an elevated hs-CRP (high sensitivity CRP).
As has been pointed out (see here for Sandy Szwarc's detailed comments and critique on the study (Jupiter) that lead to the panel's decision) a very large number of people would be "eligible" for this new indication.I believe her comments contain several important counter-points to the avalanche of glowing comments from well known "thought leaders" that came quickly on the heels of the publication of Jupiter in the NEJM and should be read by someone before planning to check everyone's CRP and treat those eligible folks with CRPs of over 2.Although, I'll bet that the media blitz and specialty society guideline publicity that will blare forth if and when the FDA gives final approval will overwhelm any suggestion by a physician that we might give the matter a little thought before we prescribe Crestor because of an elevated CRP.
A 2009 article by Dr. Erica Spatz concluded " JUPITER’s findings have the potential to impact treatment recommendations for 20% of middle-aged to elderly adults, thus increasing the proportion of this segment of the population with an indication for statin therapy to nearly 80%."
That 80% of middle-aged and elderly should be on a statin is ,to put it mildly, mind boggling.
One comment by a FDA panel member caught my eye-that the increases of new onset diabetes in the Jupiter trial was a "class effect" meaning that all statins tend to do that. For the number of patients for whom I recommended statins I did not see fit to warn them about an increased risk of diabetes. I was not aware of any. In fact, the West of Scotland study (WOSCOPS) found a 30% reduction in the onset of new diabetes in the pravastatin treatment arm. JUPITER had reported the opposite namely that there were 3% new diabetes cases in the treatment arm versus 2.4% in the placebo group. Further, Rajpathak published a meta-analysis of six statin trials that demonstrated a slight increase if the WOSCOPS data were excluded but no difference in onset of diabetes when that data were included. ( I never did understand why they would want to exclude the Scotland study anyway but...) So, if it is a class effect it must be a rather small one and I would worry more about muscle toxicity related side effects in the newly enlarged pool of older eligible patients.
So much has been written,just in the medical blog world,that I won't try and summarize all of the gleeful announcements of a really big breakthrough or the more somber critiques. But if you read only one commentary this one by DrRich would be worthwhile.
You can talk about the fact that Jupiter was terminated prematurely, you can talk about relative risk versus absolute risk reduction and Crestor effect versus class effect but in the end here is the way things seems to work. When you have a large randomized clinical trial that demonstrates a benefit for a given medication and when many well known medical thought leaders endorse it and when it is then approved by the FDA you know that guidelines will be written and quality rule driven medical practitioners will follow and many patients will take the medication and likely insurance companies will pay for some or all of it.So in this case many folks will have their hs-crp checked and they will be prescribed Crestor ( a few will be given lower price statin cousins) and there will be- for a while- talk about crp at parties.
My first prediction for the new year: Look for a surge of CME-oid meetings and articles on the value of CRP for cardiac risk assessment and as basis for statin therapy.Yes, we have heard about CRP for quite a while but soon we will probably have the blessing of the FDA and things will really take off.
Friday, December 11, 2009
What do we really know about Tamiflu and flu?
The latest word ( but likely not the last) on the use of the neuraminidase inhibitors (Tamiflu and Relenza) comes from the Evidence Based Medicine epicenter, The Cochrane review) and can be found here.
The article in the BMJ did not go unnoticed by Dr. Howard Brody who correctly recognized that there was more there than simply a lack of definitive data about the role of Tamiflu. See here for his blog comments regarding that series of events in the broader context of an integrity crisis in medical research which I believe is part of an even broader context of "How the heck do we know what is correct in medical research publications".
An ingrained as Tamiflu is in the current medical thinking about management of flu (and anything that looks like flu) I doubt the BMJ article will have any significant impact on the sales of the drug. I bet that sometime in the near future we will see a meta-analysis to counter the analysis from Cochrane.
The article in the BMJ did not go unnoticed by Dr. Howard Brody who correctly recognized that there was more there than simply a lack of definitive data about the role of Tamiflu. See here for his blog comments regarding that series of events in the broader context of an integrity crisis in medical research which I believe is part of an even broader context of "How the heck do we know what is correct in medical research publications".
An ingrained as Tamiflu is in the current medical thinking about management of flu (and anything that looks like flu) I doubt the BMJ article will have any significant impact on the sales of the drug. I bet that sometime in the near future we will see a meta-analysis to counter the analysis from Cochrane.
Thursday, December 10, 2009
Will the senate Health care reconstruction bill cover acupuncture and bee pollen? Maybe
The answer seems to be "maybe" because while there is no specific mention of bee pollen ( no, I have not read the entire bill to be sure there is in fact no mention of bees) there is the issue of interpretation of the "non-discrimination provision which is discussed here. (h/t to John Goodman).The hyperlink cited also has a link to the bill itself)
The provision at issue states that insurers shall not discriminate against any health care provider that is licensed by the state. Many states do license "providers" who are,to be politically correct,alternative medicine practitioners. So does it follow that insurers will have to pay for whatever brand of woo dished out by certain alternative woo providers as long as they are licensed by the state?
The alternative medicine lobby along with the lobbyists for supplements would seem to be happy with the senate bill and both Senator Harry Reid and Senator Harkin also with Senator Hatch seem supportive of both interests according to the LA Times article referenced above.
How many more gems of silliness and special interest provisions will turn up in the compromise bill once the Senate passes something?
The provision at issue states that insurers shall not discriminate against any health care provider that is licensed by the state. Many states do license "providers" who are,to be politically correct,alternative medicine practitioners. So does it follow that insurers will have to pay for whatever brand of woo dished out by certain alternative woo providers as long as they are licensed by the state?
The alternative medicine lobby along with the lobbyists for supplements would seem to be happy with the senate bill and both Senator Harry Reid and Senator Harkin also with Senator Hatch seem supportive of both interests according to the LA Times article referenced above.
How many more gems of silliness and special interest provisions will turn up in the compromise bill once the Senate passes something?
Thursday, December 03, 2009
Maybe we should worry more about Lemierre Syndrome than rheumatic fever given a sore throat in adolescents
An important and perhaps a paradigm shifting article is found in the Dec 1,2009 issue of the Annals of Internal Medicine by Dr.Robert Centor. See here for the abstract.For the full article subscription required or wait 6 months.
For the past many decades medical students have been taught to be wary of the possibility of the later development of rheumatic fever in a sore throat patient and that possibility is one reason for treatment of beta strep sore throats,suppurative complication being the other.
The various treatment algorithms are based on the concern about beta strep infection but Centor warns us that a different bacteria may pose a greater risk in one age group, one that seemingly is not considered in the usual treatment guidelines.
Dr Centor puts forth a good argument that in the age group 15-24 years an equally important concern (perhaps a greater concern) is that the pharyngitis is due to Fusobacterium necrophurum and if so there is a real risk of the subsequent development of something called Lemierre syndrome . This is a potentially life threatening condition in which there is bacteremia and a suppurative thrombophebitits of the internal jugular vein. While rheumatic fever and patients with rheumatic heart disease were common when I trained in the late sixties and early seventies, can anyone remember the last case of rheumatic fever that they saw?
A clinical pearl is that typically worsening clinical symptoms with neck swelling in a 15-24 year old may signal the condition. Treatment for a beta-strep negative patient in whom you suspect F. necrophorum is with penicillin or a cephalosporin and not the ever popular macrolides. With bacteremia the recommended treatment is penicillin plus metronidazole or clindamycin alone.
Robert Centor has studied and written extensively on the topic of pharyngitis for a number of years he should be listened to and hopefully his article in this widely read journal will have some impact. Any bacteria with "necro" in its name should be taken seriously. Go here to his blog to read some of his comments on this issue.
For the past many decades medical students have been taught to be wary of the possibility of the later development of rheumatic fever in a sore throat patient and that possibility is one reason for treatment of beta strep sore throats,suppurative complication being the other.
The various treatment algorithms are based on the concern about beta strep infection but Centor warns us that a different bacteria may pose a greater risk in one age group, one that seemingly is not considered in the usual treatment guidelines.
Dr Centor puts forth a good argument that in the age group 15-24 years an equally important concern (perhaps a greater concern) is that the pharyngitis is due to Fusobacterium necrophurum and if so there is a real risk of the subsequent development of something called Lemierre syndrome . This is a potentially life threatening condition in which there is bacteremia and a suppurative thrombophebitits of the internal jugular vein. While rheumatic fever and patients with rheumatic heart disease were common when I trained in the late sixties and early seventies, can anyone remember the last case of rheumatic fever that they saw?
A clinical pearl is that typically worsening clinical symptoms with neck swelling in a 15-24 year old may signal the condition. Treatment for a beta-strep negative patient in whom you suspect F. necrophorum is with penicillin or a cephalosporin and not the ever popular macrolides. With bacteremia the recommended treatment is penicillin plus metronidazole or clindamycin alone.
Robert Centor has studied and written extensively on the topic of pharyngitis for a number of years he should be listened to and hopefully his article in this widely read journal will have some impact. Any bacteria with "necro" in its name should be taken seriously. Go here to his blog to read some of his comments on this issue.
Diminishing returns on heart attack treatment innovation leads to new targets
JAMA offers this excellent commentary on the topic of diminishing returns in reducing mortality in the treatment of myocardial infarction by further therapeutic innovations.We have come a long way but to go much further in terms of mortality reduction becomes progressively more difficult and this can be expressed both in terms of cost of the clinical trial and the number needed to enroll in clinical trials.
How far have we come? Consider ISIS 2 and the subsequent innovations in the treatment of acute myocardial infarction.
ISIS2 was published in 1988 and demonstrated that the combination of aspirin and streptokinase decreased the 35 day mortality from acute myocardial infarction from 13.2 % ( in the control group) to 8 % in the treatment arm.This is a five percent absolute reduction and about a 20% decrease in relative risk.
Over the next decade or two we saw the introduction of TPA ,and angioplasty and then coronary artery stents and drugs to inhibit the platelets and the mortality rate dropped to around 4%.In some more recent trials the mortality rate of acute MI is actually closer to 2%.
The authors assert that ...it is a mathematical truism that , given the diminished control rate,future innovations can never match the benefits already realized (at least in terms of case fatality).
( by "control rate" the authors mean the rate of death in an control group as it would be constituted today with the current standard of care)
Why not? Is it simply the mathematics involved?
They explain that the mortality reduction by successive trials with a constant relative risk reduction can be characterized by a declining exponential function for mortality and an increasing exponential function for the sample size necessary to show the effect. (Their mathematical argument seems reasonable to me but I'll admit I am easy to fool with that type of thing)
The argument continues that if larger and larger sample sizes will be required then the use of surrogate measures and combined end points increasingly come into play.Also those planning clinical trials will turn to the use of control groups with higher rates of mortality as can be found in less developed countries and utilize non-inferiority trials.It does seem we have be seeing more and more of these type trials particularly trials with combined end points .
How far have we come? Consider ISIS 2 and the subsequent innovations in the treatment of acute myocardial infarction.
ISIS2 was published in 1988 and demonstrated that the combination of aspirin and streptokinase decreased the 35 day mortality from acute myocardial infarction from 13.2 % ( in the control group) to 8 % in the treatment arm.This is a five percent absolute reduction and about a 20% decrease in relative risk.
Over the next decade or two we saw the introduction of TPA ,and angioplasty and then coronary artery stents and drugs to inhibit the platelets and the mortality rate dropped to around 4%.In some more recent trials the mortality rate of acute MI is actually closer to 2%.
The authors assert that ...it is a mathematical truism that , given the diminished control rate,future innovations can never match the benefits already realized (at least in terms of case fatality).
( by "control rate" the authors mean the rate of death in an control group as it would be constituted today with the current standard of care)
Why not? Is it simply the mathematics involved?
They explain that the mortality reduction by successive trials with a constant relative risk reduction can be characterized by a declining exponential function for mortality and an increasing exponential function for the sample size necessary to show the effect. (Their mathematical argument seems reasonable to me but I'll admit I am easy to fool with that type of thing)
The argument continues that if larger and larger sample sizes will be required then the use of surrogate measures and combined end points increasingly come into play.Also those planning clinical trials will turn to the use of control groups with higher rates of mortality as can be found in less developed countries and utilize non-inferiority trials.It does seem we have be seeing more and more of these type trials particularly trials with combined end points .
Monday, November 30, 2009
Excellent new blog on "evidence" and medicine
A new medical blog named simply "Evidence" has appeared recently and it is definitely worth reading. The author identifies himself as an academic primary care physician named David Rind.
The following quote was worth the price of admission to the author's latest commentary:
There is no path from evidence to understanding that does not rely on expert interpretation, and, ultimately, no mechanical measure of sufficient evidence or proof outside of what counts as proof to those patients and providers who must make decisions.
Addendum: I neglected to give a link.Here it is.
The following quote was worth the price of admission to the author's latest commentary:
There is no path from evidence to understanding that does not rely on expert interpretation, and, ultimately, no mechanical measure of sufficient evidence or proof outside of what counts as proof to those patients and providers who must make decisions.
Addendum: I neglected to give a link.Here it is.
Thursday, November 26, 2009
Proposed Senate Health care bill shows us how regulatory capture can really work
If you thought the inclusion of industry representatives on the government proposed "CER panel" illustrated regulatory capture, you, of course, were right. But it gets even worse, much worse. Go here to read about it on Health Care Renewal as Dr. Roy Poses explains how bad it is.He also references a NEJM commentary on that subject which should be widely read and discussed and might give some pause to those who seem to assume that the purported intent of legislation and the likely consequences are the same thing.
Here is the essence of this new outrage.I am quoting from Poses's blog entry.
Here is the essence of this new outrage.I am quoting from Poses's blog entry.
The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not within the bounds of and entirely consistent with the evidence.' Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome.Comparative effectiveness research in the ideal and what it may turn into with the passage of this provision have as much in common as a warm puppy and a hot dog.
Saturday, November 21, 2009
Physicians and patients will both pay more attention to the USPSTF after medical care is "reformed"
Very newsworthy in recent days has been the publication of the latest recommendations from the USPSTF regarding mammograms. Surprising to many and shocking to some were the changes from earlier recommendations and the degree to which they differ from the widely disseminated and adhered to recommendations of the American Cancer Society.
Seemingly to allay some of the shock and likely backlash from those who fear and/or write about the "r" word (rationing) in regard to health care , HHS Secretary Sebelius told the country not to worry about their recommendations regarding women less than fifty and over seventy-five .She reassured everyone that- no these are not binding to Medicare or to any insurance company and for everyone to go along just as they had before and be sure to check with their physician about proper advice in that regard.
DrRich of The Covert Rationing Blog dug through goodness knows how many pages of HR 3962 and pulled out some very interesting, and to some of us, very alarming provisions. Go here to read what he found.
HR 3962 provisions, if they survive, will elevate the USPSTF to something much more than an advisory body and morph them in to an entity named TFCPS (Task Force on Clinical Preventive Services) and when they make an "A" or a "B" level recommendation that will become part of the essential package that will be required to be included the coverage of "qualified health plans".
But there is even more. Not just incorporating future recommendation of the TFCPS aka USPSTF the HHS Secretary will go back and use their previous recommendations as policy. Here is a quote from the bill as reported by DrRich;
“All recommendations of the Preventive Services Task Force and the Task Force on Community Preventive Services, as in existence on the day before the date of the enactment of this Act, shall be considered to be recommendations of the Task Force on Clinical Preventive Services and the Task Force on Community Preventive Services, respectively, established under sections 3131 and 3132 of the Public Health Service Act, as added by subsection (a).” (Section 3171, page 1319).
Since all their current recommendation may become policy not only should the breast cancer/mammograms interest groups be very interested, so should others and they read through their 2009 set of recommendations here.
The American college of Radiology alertly recognized what clout the USPSTF is likely to have and recommend that the USPSTF change its stance (fat chance of that) and/or for whatever deliberative body there will be to be more "inclusive".
In regard to the more narrow issue of what lead the USPSTF folks to reach their conclusion, this analysis by Dr. John Goodman is worthy considering. Apparently the issue of false positives and the necessary and costly followup weighed fairly heavy in their calculus. ( Aside, warning biased anecdote to follow -- in the years when I recommended PSA screening, over a five year period 12 cancers were detected and another 6 patients were evaluated and no cancer was found.Interesting the false positive group all expressed relief that they did not have cancer a view that I have also observed in other patients who had a scare based on a lab test.) From what I have observed the false positive issue is larger in the eyes of those who write guidelines and they speak of anxiety but really are concerned over aggregate cost that accrues when false positives are further evaluated.
Dr. Mark J Perry, an economist from the University of Michigan, makes insightful comments here regarding this issue.In the world of HSA (Health Saving Accounts ),which are under assault in the senate health care bill, the pronouncements of the USPSTF would not be determinative and the individual patient could confer with her individual physician to decide when and if you get mammograms and the secretary of HHS would not be in charge.
Seemingly to allay some of the shock and likely backlash from those who fear and/or write about the "r" word (rationing) in regard to health care , HHS Secretary Sebelius told the country not to worry about their recommendations regarding women less than fifty and over seventy-five .She reassured everyone that- no these are not binding to Medicare or to any insurance company and for everyone to go along just as they had before and be sure to check with their physician about proper advice in that regard.
DrRich of The Covert Rationing Blog dug through goodness knows how many pages of HR 3962 and pulled out some very interesting, and to some of us, very alarming provisions. Go here to read what he found.
HR 3962 provisions, if they survive, will elevate the USPSTF to something much more than an advisory body and morph them in to an entity named TFCPS (Task Force on Clinical Preventive Services) and when they make an "A" or a "B" level recommendation that will become part of the essential package that will be required to be included the coverage of "qualified health plans".
But there is even more. Not just incorporating future recommendation of the TFCPS aka USPSTF the HHS Secretary will go back and use their previous recommendations as policy. Here is a quote from the bill as reported by DrRich;
“All recommendations of the Preventive Services Task Force and the Task Force on Community Preventive Services, as in existence on the day before the date of the enactment of this Act, shall be considered to be recommendations of the Task Force on Clinical Preventive Services and the Task Force on Community Preventive Services, respectively, established under sections 3131 and 3132 of the Public Health Service Act, as added by subsection (a).” (Section 3171, page 1319).
Since all their current recommendation may become policy not only should the breast cancer/mammograms interest groups be very interested, so should others and they read through their 2009 set of recommendations here.
The American college of Radiology alertly recognized what clout the USPSTF is likely to have and recommend that the USPSTF change its stance (fat chance of that) and/or for whatever deliberative body there will be to be more "inclusive".
In regard to the more narrow issue of what lead the USPSTF folks to reach their conclusion, this analysis by Dr. John Goodman is worthy considering. Apparently the issue of false positives and the necessary and costly followup weighed fairly heavy in their calculus. ( Aside, warning biased anecdote to follow -- in the years when I recommended PSA screening, over a five year period 12 cancers were detected and another 6 patients were evaluated and no cancer was found.Interesting the false positive group all expressed relief that they did not have cancer a view that I have also observed in other patients who had a scare based on a lab test.) From what I have observed the false positive issue is larger in the eyes of those who write guidelines and they speak of anxiety but really are concerned over aggregate cost that accrues when false positives are further evaluated.
Dr. Mark J Perry, an economist from the University of Michigan, makes insightful comments here regarding this issue.In the world of HSA (Health Saving Accounts ),which are under assault in the senate health care bill, the pronouncements of the USPSTF would not be determinative and the individual patient could confer with her individual physician to decide when and if you get mammograms and the secretary of HHS would not be in charge.
Friday, November 20, 2009
Still more worries regarding clopidogel and PPIs
Previously on Retired Doc, I commented that first we were warned about a drug-drug interaction in which PPIs ( or at least omeprazole ) mitigated the therapeutic effect of clopidogrel in a clinically important way and then a randomized clinical may have failed to showed such a relationship.Now we need to worry again.
See here for comments about what the FDA is now saying about the combo of clopidogrel and omeprazole suggesting we need to dust of the H2 blockers rather than using the PPIs. Bad news for the PPIs but possibly good news for ticagrelor since it is, unlike clopidogrel, apparently not a prodrug and drug-drug interactions will be less likely.Then again look how long both Plavix and Prolosec were used before we had data sufficient to worry about that interaction.
See here for comments about what the FDA is now saying about the combo of clopidogrel and omeprazole suggesting we need to dust of the H2 blockers rather than using the PPIs. Bad news for the PPIs but possibly good news for ticagrelor since it is, unlike clopidogrel, apparently not a prodrug and drug-drug interactions will be less likely.Then again look how long both Plavix and Prolosec were used before we had data sufficient to worry about that interaction.
Monday, November 16, 2009
Health care (insurance) bill has what in common with the Mafia?
I had promised myself (fingers crossed behind the back) not to comment further on the health insurance bill after reading the comments of Bill Clinton and Rahm Emanuel to the effect of let's pass something and worry about what later.
But, the title ( an offer you can't refuse) alone of this entry by Dr. Paul Hsieh is worth the price of admission.Also his review of how well Mass-care is working is well done and should be a cautionary tale but I am increasingly convinced it is not about what is in the bill but just that something gets passed and not about rational arguments pro and con but about what deals are made to get something passed.
But, the title ( an offer you can't refuse) alone of this entry by Dr. Paul Hsieh is worth the price of admission.Also his review of how well Mass-care is working is well done and should be a cautionary tale but I am increasingly convinced it is not about what is in the bill but just that something gets passed and not about rational arguments pro and con but about what deals are made to get something passed.
Tuesday, November 10, 2009
Follow the money (or promise of it) to see why AMA and AARP support the health care bill(s)
See this article for one explanation for why AARP might support the current democratic health care "reform" bill. This is from the pen of Dick Morris and his assertion is that AARP in its role as an insurance broker will reap rewards from the bill(s) cutting funds to Medicare Advantage as a number of old folks will then need/want to buy medicare supplemental insurance for which AARP is a major broker.
How does this "follow the money rule" work for the AMA support of the bill(s)? Again Morris suggests a deal with the Obama administration , one in which AMA is promised that the dreaded and dreadful SGR annual cuts will be abolished. He does not spell out the evidence that such a deal was made and if so what was the deal.
Morris's article also tackles the relationship of the drug companies,insurance companies and medical device companies regarding their support or lack thereof and what they might or might not get out of it all.
'Follow the money" continues to be a very useful insight-generating rule or at least a hint as to what rocks to look under.
How does this "follow the money rule" work for the AMA support of the bill(s)? Again Morris suggests a deal with the Obama administration , one in which AMA is promised that the dreaded and dreadful SGR annual cuts will be abolished. He does not spell out the evidence that such a deal was made and if so what was the deal.
Morris's article also tackles the relationship of the drug companies,insurance companies and medical device companies regarding their support or lack thereof and what they might or might not get out of it all.
'Follow the money" continues to be a very useful insight-generating rule or at least a hint as to what rocks to look under.
Monday, November 09, 2009
The very best comment regarding HR 3962
I am not surprised that the comment was offered by DrRich on his blog Covert Rationing. Here is his entire commentary and here is the great quote by James Madison regarding which DrRich reminds us:
“It will be of little avail to the people, that the laws are made by men of their own choice, if the laws be so voluminous that they cannot be read, or so incoherent that they cannot be understood…” - The Federalist #62
“It will be of little avail to the people, that the laws are made by men of their own choice, if the laws be so voluminous that they cannot be read, or so incoherent that they cannot be understood…” - The Federalist #62
Will the house and senate bills raise insurance premiums and actually decrease coverage?
According to Harvard economist Martin Feldstein they may well. See his article here. Here is how that could work.
If the monetary fine for not having insurance is less than the premiums on available insurance AND a person can get insurance AFTER a medical condition occurs, a rational strategy would seem to be to not insure yourself , pay the fine and wait until you need insurance and then buy some. Is this really a major flaw in the Pelosi bill ? Will this be a flaw that will defeat some of the purported purposes of the legislation?
Economists are fond are saying that economics is largely about incentives.If Dr. Feldstein is reporting the facts of the bill accurately and unless the bill somehow repeals human nature , it appears that one of the purported aims of the "reform",namely to insure [almost]everyone will not be achieved. He argues further as to what might happen as the number of insured actually decline:
But as the number of those who are currently insured declines, a future Congress might respond by increasing subsidies to middle- and upper-income individuals to buy private insurance. More likely, it would subsidize a public insurance company--whether or not such a public option is in the initial law--just as it now subsidizes Medicare in a way that was not contemplated when the Medicare program was created.
So, it seems even if there is no public option provision enacted now the consequences of certain other provisions will make it come to pass later on anyway. So, it is a flaw or a clever ploy?
If the monetary fine for not having insurance is less than the premiums on available insurance AND a person can get insurance AFTER a medical condition occurs, a rational strategy would seem to be to not insure yourself , pay the fine and wait until you need insurance and then buy some. Is this really a major flaw in the Pelosi bill ? Will this be a flaw that will defeat some of the purported purposes of the legislation?
Economists are fond are saying that economics is largely about incentives.If Dr. Feldstein is reporting the facts of the bill accurately and unless the bill somehow repeals human nature , it appears that one of the purported aims of the "reform",namely to insure [almost]everyone will not be achieved. He argues further as to what might happen as the number of insured actually decline:
But as the number of those who are currently insured declines, a future Congress might respond by increasing subsidies to middle- and upper-income individuals to buy private insurance. More likely, it would subsidize a public insurance company--whether or not such a public option is in the initial law--just as it now subsidizes Medicare in a way that was not contemplated when the Medicare program was created.
So, it seems even if there is no public option provision enacted now the consequences of certain other provisions will make it come to pass later on anyway. So, it is a flaw or a clever ploy?
Monday, November 02, 2009
Tight control blood sugar- Pendulum swings back a bit
A recent systematic review by Kelly et al in the Annals of Internal Medicine tackled the issue of glucose control and cardiovascular disease risk in type 2 diabetes.(Annals of Internal Medicine,15 September,2009,vol 151, no 6 p 384.) The authors found by combining data from 28,000 patients from 5 large randomized trial that there was an approximate 10% decrease in the risk for coronary heart disease (largely from decrease in non-fatal myocardial infarctions) but no overall effect on cardiovascular or all cause mortality.The authors' take on the situation is that since there is no apparent benefit from tight control in terms of overall mortality or cardiovascular disease mortality and the risk of serious hypoglycemia is real that the emphasis should be on total risk reduction in terms of optimal control of blood pressure and cholesterol and use of aspirin because in part those maneuvers have been shown to significantly reduce cvd and all-cause mortality.
In the last year, three studies have been published which seem to dash the hopes of those who hoped for a significant decrease in cardiovascular risk by tighter glucose control. Two trials ( ADVANCE and VADT showed no decrease in CV events with tighter control and one trial has even worse news.The ACCORD trial found an increased risk for CV deaths and total mortality in the group treated with intensive glucose control.(more comment on that trial below)
I thought it would be a good time to reprint a commentary I previously made on that general theme.
The following is a slightly re-edited version of comments I made two years ago.
How many evening diner,CMEoid sessions included the chant, "treat to goal,treat to goal" in regard to blood sugar. As with LDl cholesterol-the goal just kept getting lower and lower.
The DPPT study seemed to provide very good evidence that the microvascular complications of type 1 diabetes could be significantly mitigated by "good"control of blood sugar.Later a follow up report from that landmark trial also provided some reasonable evidence that perhaps macrovascular disease could also be decreased.
Many had hoped that we could accomplish the same reduction in the complications of type 2 diabetes by a similar surge of intensive treatment aimed at bringing about near normoglycemia. Would that life and disease and managing disease were so simple.
The DPPT was a fairly simple trial. There were patients with a disease that seems fairly homogeneous and has relatively straightforward pathophysiology ,i.e insulin lack from the clinical beginning and the treatment intervention was simply more insulin. On the other hand, the UKPDS trial involved several treatment arms and greater heterogeneity of comorbid conditions in the subjects as well as more variation in the the tempo of the various pathophysiological disturbances and the fact that the pathophysiology of type 2 is much more complex than in type 1 and is still being worked out, as exemplified by the recent surge of interest in the role and therapeutic manipulation of the incretin family in type 2.
With trials with more complicated conditions and multiple treatment arms there is greater likelihood of chance and confounding and various biases clouding the results. Clouded results or not the UKPDS became a major element in the argument to treat to lower blood glucose value in type 2 diabetes. The results of the UKPDS were not earth moving but were encouraging. There was some decrease in blood vessel disease on retinal exam and some decrease in the rate of progression of urinary protein leak but no change in renal failure or blindness or clinical manifestations of macrovascular disease. The benefit in terms of reduction of retinal microvascular and perhaps renal disease was arguably balanced by an almost four fold increase in serious hypoglycemia episodes ( 0.6% per year versus 2.3%). The former effect was emphasized and the later effect was not in the 2002 position paper from the American diabetes Association from which a lot of the enthusiasm for tight control arose.
Now fast forward to the ACCORD trial . Here is the announcement of the cancellation of the intensive treatment arm of this large randomized trial. This was supposed to be the trial that would answer-among other questions- the question "can we decrease the macrovascular events associated with type 2 diabetes with intensive blood glucose control ?" Here the treatment goal was a HbA1C of less than 6 %, i.e. basically normal.
However,there were more overall deaths in the intensive treatment arm than in the standard treatment arm. Of those intensively treated about 1/2 had hemoglobin A1C values of less than 6.4 while in the standard treatment arm 1/2 had value less than 7.5. The mortality increase was certainly not what the investigators likely expected.The overall death rate was reported as 20% higher but there were actually fewer heart attacks in the intensive treatment arm but of those there was a higher mortality. So what is happening to cause increase mortality? The NIH announced their analysis so far has not determined what factor(s) are to blame.
Is this simply a matter of getting the glucose too low? Maybe, but an early report from the trial claimed that the excess mortality was not related to hypoglycemia although there were expectedly more hypoglycemia episodes in the intensive treatment group. Although rosiglitazone's role in the disappointing results has been battered back and forth the authors of the current Annals review comment that rosi was more commnly used in the intensive arm than in the control arm of ACCORD.
Dr. RW suggested that excessive insulin use may really be the culprit though not necessarily by precipitating hypoglycemia episodes but by fueling weight gain and the metabolic syndrome and insulin resistance. Other suggestions have been made,see here for references, including the stress placed on patients to achieve a difficult therapeutic goal and the theory that too rapid decrease in blood glucose might have played a role.
Various commentators have had their say regarding this trial and some have attempted to give it a bit better spin,but deaths are not a surrogate measure and the major observation of more deaths with intensive treatment may well shift the momentum of diabetic treatment from "lower is better" to "well maybe not too low" and maybe " not necessarily the same target for everyone". A number of doctor bribe programs (A.K.A. pay for performance ) are keyed to hemoglobin A1C levels .Will we see those third party payers whose interests are claimed to be in improving quality of care quickly revise their guidelines?
Physicians want better treatments for their patients and they want results of promising treatments to be true. That desire to do good for their patients coupled with big pharma funded hype often aided by a shinny veneer pasted on by academic and other thought leaders can really energize therapeutic exuberance that may have a much less robust evidentiary base that we were lead to believe.Treating to a goal or treating the numbers can make clinical life seem simpler, sometimes too simple. Of course, an A1C target was just to handy for guideline writers to ignore.
It is a good thing we quasi- codified all some things into guidelines and pay-for-compliance programs otherwise we might not have had a chance to use them before we decided there weren't really a great idea after all. I remember as house officers we used to talk about the patient dying but the electrolytes were in balance but in those days our actions were not guideline driven.
The plan to decrease cardiovascular disease morality by tight blood glucose control may not have been completely abandoned at this juncture but it is hard to locate statements as enthusiastic as the 2002 ADA position paper.
The 2006 ADA position paper offers an approach to use of the hemoglobin A1C that seems reasonable and
and allows for more nuanced clinical judgment, so do the October, 2009 recommendations of the ACCE/ACE (see here.) Here is a quotes from their recent publication emphasizing the increased risk for patients with a longer history of diabetes and implying that one size for the hemoglobin A1C may not really fit everyone.
".....the risk of cardiac events
and death is more common in patients with hypoglycemic
episodes (and especially severe hypoglycemia) and that
the benefit-to-risk ratio decreases progressively with the
duration of diabetes, such that the use of intensive therapy
may be at least relatively contraindicated in patients with
a duration of diabetes longer than 12 years (VADT) (17).
The ACCORD study (15) also suggested that excessively
rapid or aggressive adjustment of therapy may be associated
with increased risk. The A1C levels show an excellent
correlation with the mean glucose level, but this relationship
is also affected by several other factors, such as
hemoglobinopathies, hemolytic anemias, varying rates of
individual glycation, genetics, and the variabilities of different
laboratory methods."
In the last year, three studies have been published which seem to dash the hopes of those who hoped for a significant decrease in cardiovascular risk by tighter glucose control. Two trials ( ADVANCE and VADT showed no decrease in CV events with tighter control and one trial has even worse news.The ACCORD trial found an increased risk for CV deaths and total mortality in the group treated with intensive glucose control.(more comment on that trial below)
I thought it would be a good time to reprint a commentary I previously made on that general theme.
The following is a slightly re-edited version of comments I made two years ago.
How many evening diner,CMEoid sessions included the chant, "treat to goal,treat to goal" in regard to blood sugar. As with LDl cholesterol-the goal just kept getting lower and lower.
The DPPT study seemed to provide very good evidence that the microvascular complications of type 1 diabetes could be significantly mitigated by "good"control of blood sugar.Later a follow up report from that landmark trial also provided some reasonable evidence that perhaps macrovascular disease could also be decreased.
Many had hoped that we could accomplish the same reduction in the complications of type 2 diabetes by a similar surge of intensive treatment aimed at bringing about near normoglycemia. Would that life and disease and managing disease were so simple.
The DPPT was a fairly simple trial. There were patients with a disease that seems fairly homogeneous and has relatively straightforward pathophysiology ,i.e insulin lack from the clinical beginning and the treatment intervention was simply more insulin. On the other hand, the UKPDS trial involved several treatment arms and greater heterogeneity of comorbid conditions in the subjects as well as more variation in the the tempo of the various pathophysiological disturbances and the fact that the pathophysiology of type 2 is much more complex than in type 1 and is still being worked out, as exemplified by the recent surge of interest in the role and therapeutic manipulation of the incretin family in type 2.
With trials with more complicated conditions and multiple treatment arms there is greater likelihood of chance and confounding and various biases clouding the results. Clouded results or not the UKPDS became a major element in the argument to treat to lower blood glucose value in type 2 diabetes. The results of the UKPDS were not earth moving but were encouraging. There was some decrease in blood vessel disease on retinal exam and some decrease in the rate of progression of urinary protein leak but no change in renal failure or blindness or clinical manifestations of macrovascular disease. The benefit in terms of reduction of retinal microvascular and perhaps renal disease was arguably balanced by an almost four fold increase in serious hypoglycemia episodes ( 0.6% per year versus 2.3%). The former effect was emphasized and the later effect was not in the 2002 position paper from the American diabetes Association from which a lot of the enthusiasm for tight control arose.
Now fast forward to the ACCORD trial . Here is the announcement of the cancellation of the intensive treatment arm of this large randomized trial. This was supposed to be the trial that would answer-among other questions- the question "can we decrease the macrovascular events associated with type 2 diabetes with intensive blood glucose control ?" Here the treatment goal was a HbA1C of less than 6 %, i.e. basically normal.
However,there were more overall deaths in the intensive treatment arm than in the standard treatment arm. Of those intensively treated about 1/2 had hemoglobin A1C values of less than 6.4 while in the standard treatment arm 1/2 had value less than 7.5. The mortality increase was certainly not what the investigators likely expected.The overall death rate was reported as 20% higher but there were actually fewer heart attacks in the intensive treatment arm but of those there was a higher mortality. So what is happening to cause increase mortality? The NIH announced their analysis so far has not determined what factor(s) are to blame.
Is this simply a matter of getting the glucose too low? Maybe, but an early report from the trial claimed that the excess mortality was not related to hypoglycemia although there were expectedly more hypoglycemia episodes in the intensive treatment group. Although rosiglitazone's role in the disappointing results has been battered back and forth the authors of the current Annals review comment that rosi was more commnly used in the intensive arm than in the control arm of ACCORD.
Dr. RW suggested that excessive insulin use may really be the culprit though not necessarily by precipitating hypoglycemia episodes but by fueling weight gain and the metabolic syndrome and insulin resistance. Other suggestions have been made,see here for references, including the stress placed on patients to achieve a difficult therapeutic goal and the theory that too rapid decrease in blood glucose might have played a role.
Various commentators have had their say regarding this trial and some have attempted to give it a bit better spin,but deaths are not a surrogate measure and the major observation of more deaths with intensive treatment may well shift the momentum of diabetic treatment from "lower is better" to "well maybe not too low" and maybe " not necessarily the same target for everyone". A number of doctor bribe programs (A.K.A. pay for performance ) are keyed to hemoglobin A1C levels .Will we see those third party payers whose interests are claimed to be in improving quality of care quickly revise their guidelines?
Physicians want better treatments for their patients and they want results of promising treatments to be true. That desire to do good for their patients coupled with big pharma funded hype often aided by a shinny veneer pasted on by academic and other thought leaders can really energize therapeutic exuberance that may have a much less robust evidentiary base that we were lead to believe.Treating to a goal or treating the numbers can make clinical life seem simpler, sometimes too simple. Of course, an A1C target was just to handy for guideline writers to ignore.
It is a good thing we quasi- codified all some things into guidelines and pay-for-compliance programs otherwise we might not have had a chance to use them before we decided there weren't really a great idea after all. I remember as house officers we used to talk about the patient dying but the electrolytes were in balance but in those days our actions were not guideline driven.
The plan to decrease cardiovascular disease morality by tight blood glucose control may not have been completely abandoned at this juncture but it is hard to locate statements as enthusiastic as the 2002 ADA position paper.
The 2006 ADA position paper offers an approach to use of the hemoglobin A1C that seems reasonable and
and allows for more nuanced clinical judgment, so do the October, 2009 recommendations of the ACCE/ACE (see here.) Here is a quotes from their recent publication emphasizing the increased risk for patients with a longer history of diabetes and implying that one size for the hemoglobin A1C may not really fit everyone.
".....the risk of cardiac events
and death is more common in patients with hypoglycemic
episodes (and especially severe hypoglycemia) and that
the benefit-to-risk ratio decreases progressively with the
duration of diabetes, such that the use of intensive therapy
may be at least relatively contraindicated in patients with
a duration of diabetes longer than 12 years (VADT) (17).
The ACCORD study (15) also suggested that excessively
rapid or aggressive adjustment of therapy may be associated
with increased risk. The A1C levels show an excellent
correlation with the mean glucose level, but this relationship
is also affected by several other factors, such as
hemoglobinopathies, hemolytic anemias, varying rates of
individual glycation, genetics, and the variabilities of different
laboratory methods."
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